This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Biesbrock, A.R. Articles by Smith, S.R. Search for Related Content PubMed PubMed Citation Articles by Biesbrock, A.R. Articles by Smith, S.R. Pubmed/NCBI databases Medline Plus Health Information Clinical Trials Social Bookmarking                         What's this?

The Challenges of Validating Diagnostic Methods Relative to a Conventional Two-year Caries Clinical Trial

¹ Procter & Gamble Company, Cincinnati, OH, USA;
² Unilever Dental Research, Port Sunlight, Bebington, UK;
³ Colgate-Palmolive, Dental Health Unit, Manchester, UK; and
⁴ GlaxoSmithKline, Weybridge, UK;

Correspondence: corresponding author, Biesbrock.ar{at}pg.com

ABSTRACT

This paper is directed to the question, "What are the appropriate validation criteria for the use of a new clinical trial methodology as a replacement for a conventional two- to three-year caries study?" It is important to recognize that the objective of a two- to three-year randomized, controlled caries trial is to test a precisely framed hypothesis, regarding an experimental product’s efficacy relative to a control product. The external validity of conventional two- to three-year caries clinical studies in determining the efficacy and safety of anti-caries products is well-accepted. However, caries clinical trials are not without limitations and have increasingly been viewed as inefficient with respect to measuring the disease process in a holistic manner. The endpoint of a caries lesion with loss of enamel integrity (cavitation) focuses on one end of the caries progression continuum at the expense of early caries initiation and progression. Several early caries detection methods have been developed that correlate with mineral loss of the tooth surface. These diagnostics differ from conventional visual-tactile and radiographic methods in that they are capable of detecting early non-cavitated lesions, and this can generate continuous data. As diagnostic methods become accepted, they will lead to study designs that diverge from the conventional two- to three-year caries studies. Modification of the existing two- to three-year conventional caries design for assessment of product effectiveness, whether by the introduction of a new diagnostic method or by modification of the overall clinical design, must result in a clinical design that is able to differentiate known treatments on the basis of caries prevention efficacy. Given that the fluoride dose response has been characterized in the literature, this should form the basis of any validation package for new methodologies. In conclusion, a minimum expectation for acceptance as a replacement to conventional testing should be that the method or design can differentiate products of known efficacy from one another and that the efficacy relationship observed in a two- to three-year conventional study can be observed with the new method or design.

Key Words: caries • clinical trials • validation • early caries detection • diagnostics

Journal of Dental Research, Vol. 83, No. suppl 1, C53-C55 (2004)
DOI: 10.1177/154405910408301S11


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				E. Barberia, M. Maroto, M. Arenas, and C. C. Silva A Clinical Study of Caries Diagnosis With a Laser Fluorescence System J Am Dent Assoc, May 1, 2008; 139(5): 572 - 579. [Abstract] [Full Text] [PDF]

				G.K. Stookey Optical Methods--Quantitative Light Fluorescence Journal of Dental Research, July 1, 2004; 83(suppl_1): C84 - C88. [Abstract] [Full Text] [PDF]